Life sciences supply chains need to adjust to increasingly complex environments globally. Pharma manufacturers and wholesalers in Europe must undergo a fundamental transformation to remain competitive in this market. The rapidly approaching deadline of the European Union’s Falsified Medicines Directive (FMD) for drug serialization and traceability is currently the top concern of life science companies supplying pharmaceutical products to the European markets. However, companies can take this opportunity to upgrade their digital systems and operations and realize the broader potential of the 3rd platform and innovation accelerator technologies to achieve “smart compliance,” deriving a longer-term business value for their supply chains.

Life sciences supply chains today need to adjust to increasingly complex environments globally, ensuring that they are as agile and diverse as the markets they serve. Pharma manufacturers and wholesalers in Europe must undergo a fundamental transformation to remain competitive in this market. The transformation is necessitated by a range of factors related to increasingly stringent regulations, the need to support the development and distribution of novel products, shifts in the overall industry business models that require more agile, scalable, and efficient management of supply chains (in order to support, for example, patient engagement practices and personalized care models), and collaboration with a broader range of stakeholders. To gain the necessary edge to compete in the new industry environment, life sciences companies need to radically redesign their supply chains, leveraging new and emerging technologies in order to make this vital transformation happen.

Theevolving regulatory mandates cannot be accommodated by the traditional supply chain models, as they cannot support the required levels of integration, safety, and transparency. With just a couple of months remaining before the February 9, 2019 deadline, the most urgent regulatory concerns relate to the fast-approaching deadline for unit-level drug serialization set forth by the the EU’s Falsified Medicines Directive (FMD).

FMD compliance makes a certain level of digital investments and efforts unavoidable for life science supply chain firms in Europe. Fortunately, with the right set of digital technologies, the value of these investments can be extended beyond “basic” compliance. In recently published studies, IDC Health Insights has explored the issue in depth, proposing that life science companies take a more proactive, comprehensive STAR(S)2 approach to FMD requirements. The STAR(S)2is about achieving “smart compliance”, using this opportunity to fundamentally transform supply chain operations to make them future-ready. The STAR(S)2 approach recognizes the broader digital transformation potential that can be achieved through a smart combination of new and emerging technologies, such as cloud, mobile, the Internet of Things, Big Data/analytics, artificial intelligence, and blockchain.